All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present subject matter. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed subject matter, or that any publication specifically or implicitly referenced is prior art.
Pericardiocentesis is a procedure wherein the fluid in the pericardium is aspirated. Fluid aspiration is necessary to relieve the pressure on the heart or to analyze the fluid surrounding the heart. Examples of indications for pericardiocentesis include but are not limited to cardiac tamponade, pericarditis, and pericardial effusion. In instances wherein long term drainage is necessary, a cardiothoracic surgeon will create a pericardial window, in which an opening is made in the pericardium to drain the fluid. The procedure is known as a pericardiotomy or pericardiostomy.
Balloon dilation of the pericardium is currently performed with an aortic balloon valvuloplasty catheter. Percutaneous balloon pericardiotomy is a percutaneous procedure using a balloon catheter to produce a pericardial window, in effect, by tearing the pericardium in patients with pericardial effusion. The procedure is typically an alternative to conventional pericardiotomy to avoid surgery in patients with a poor prognosis. Percutaneous pericardiotomy procedures have been performed with a single or double balloon catheter. Generally, the procedure involves having the balloon span across the pericardium and quickly inflating the balloon to create the pericardial window and is performed under fluoroscopic guidance to ensure that the balloon spans across the pericardium and that a pericardial window is created.
Nonetheless, these procedures require fluoroscopic guidance and a highly skilled interventional cardiologist. Thus, there exists a need in the art for a device and a method for percutaneous pericardiotomy that does not require the fluoroscopic guidance and that may be more simple to perform.